- Develop and qualify flow cytometry and other cell-based methods to measure gene editing, gene expression, and function. Examples include measurements of T cell subsets, exhaustion markers, and CAR expression in immuno-oncology products.
- Act as point person to conduct key analytical testing to characterize cellular drug products.
- Collaborate with Process Development to generate and analyze process development data to develop an understanding of cellular product critical quality attributes to guide testing and process control strategies.
- Develop data sets supporting product specification and for qualification and/or validation of cell-based assays at CMOs and GMP test labs.
- Maintain clear and complete experimental records. Present findings in meetings.
- Document development activities in Technical Reports supporting regulatory filings.
- Support drafting and revising protocols, SOPs and regulatory sections for filings.
- BS in life sciences with 5+ years of relevant assay development experience in industry or an MS with 3+ years of relevant experience.
- Flow cytometry experience is a must. Ability to design and execute multi-color flow cytometry experiments. Ability to analyze complex data sets and troubleshoot.
- Experience with cell-based assay development for immunology or immuno-oncology products.
- Experience with a range of cell and molecular biology techniques.
- Ability to work independently as well as part of a fast-paced, results-oriented team.
- Excellent oral and written communication skills.
- Highly organized with significant attention to detail.
- Track record of intellectually challenging oneself to enhance scientific abilities.
- Experience in assay development for cell and gene therapy products.
- Experience in analytical method qualification and validation.
- Knowledge of relevant guidance on analytical development and validation (USP, ICH, FDA, EMA).
- Experience working with contract manufacturing organizations and in tech transfer to QC labs.
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